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NCT ID: NCT01972295 Completed - Atrial Fibrillation Clinical Trials

Registry on WATCHMAN Outcomes in Real-Life Utilization WASP Registry

WASP
Start date: January 13, 2014
Phase:
Study type: Observational [Patient Registry]

This is an observational, prospective, non-randomized, multicenter study with the following objectives: (1) to compile real-world clinical outcomes data for WATCHMAN Left Atrial Appendage Closure Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect health care usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

NCT ID: NCT01972282 Completed - Clinical trials for Patients With Atrial Fibrillation at Risk for Thrombus Formation, Thromboembolism, Stroke

Registry on WATCHMAN Outcomes in Real-Life Utilization

EWOLUTION
Start date: October 28, 2013
Phase:
Study type: Observational [Patient Registry]

The WATCHMAN LAA Closure Technology is designed to prevent embolization of thrombi that may form in the LAA, thereby preventing the occurrence of ischemic stroke and systemic thromboembolism. The objectives of this observational, prospective, non-randomized multicenter study are (1) to compile real-world clinical outcomes data for WATCHMAN LAA (left atrial appendage) Close Technology in patients who are implanted with the WATCHMAN device in a commercial clinical setting and (2) to collect real-world usage data that may be needed for reimbursement of WATCHMAN technology in certain countries.

NCT ID: NCT01964391 Completed - Breast Cancer Clinical Trials

A Study of Participant Satisfaction and Safety With Subcutaneously Administered Trastuzumab (Herceptin) in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Early Breast Cancer

Start date: February 21, 2014
Phase: Phase 3
Study type: Interventional

This Phase IIIb, open-label, multinational, multicenter study will evaluate the participant's satisfaction and safety with subcutaneously administered trastuzumab in participants with HER2-positive early breast cancer. Participants will receive trastuzumab 600 milligrams (mg) administered subcutaneously every 3 weeks in the adjuvant or neo-adjuvant plus adjuvant setting for 18 cycles (1 year), unless disease progression or unacceptable toxicity occurs. The trastuzumab regimen could include mono- and/or combination therapy.

NCT ID: NCT01958567 Completed - Clinical trials for Scleritis and Episcleritis

Optical Coherence Tomography in the Diagnosis of Scleritis and Episcleritis

Start date: July 2012
Phase: N/A
Study type: Interventional

The main purpose of this study is to describe the optical coherence tomography (OCT) findings in eyes with scleral inflammation and to differentiate cases with anterior scleritis from those with episcleritis and normal controls.

NCT ID: NCT01950819 Completed - Hemodialysis Clinical Trials

Advancing Renal TRANSplant eFficacy and Safety Outcomes With an eveRolimus-based regiMen (TRANSFORM)

TRANSFORM
Start date: December 3, 2013
Phase: Phase 4
Study type: Interventional

This is a 2-year, randomized, multicenter, open-label, 2-arm study evaluating the graft function of everolimus and reduced CNI versus MPA and standard CNI in adult de novo renal transplant recipients.

NCT ID: NCT01941238 Completed - Type 1 Diabetes Clinical Trials

Incidence of Hypoglycemia During Ramadan in Patients With Type1 Diabetes on Insulin Pump Versus Multi Dose Injection

Start date: July 2013
Phase: N/A
Study type: Observational

Managing patients with type1 diabetes when fasting Ramadan is very challenging. Insulin pump offers the advantage of flexibility and precision to administering insulin and has been proven to reduce severe hypoglycemia compared to multi-dose injection (MDI). However, there are extremely limited studies on the difference between insulin pump compared to MDI on the incidence of hypoglycemia and other acute complications during fasting Ramadan The investigators hypothesized that insulin pump would be associated with less hypoglycemic events during fasting Ramadan compared to MDI without deterioration in glycemic control. Results of this study are descriptive but will fill a current gap in knowledge and may contribute to development of future guidelines for the management of type1DM during Ramadan.

NCT ID: NCT01937234 Completed - Clinical trials for Prolonged First Stage of Labor

Use of an Antiemetic to Shorten the Length of Labor in Nulliparous Women

Start date: July 2013
Phase: Phase 4
Study type: Interventional

Reducing the length of labor is a highly desirable goal of intrapartum care, both from a perspective of maternal and fetal well-being , and for the providers of the birth services. Avoiding a long , protracted labor entails shorter exposure to pain anxiety and stress and would translate into a major improvement in maternal satisfaction with the child birth experience. The purpose of this study is to determine the effectiveness of metoclopramide for reducing the duration of spontaneous labor among nulliparous women managed according to a standard intrapartum protocol.

NCT ID: NCT01935804 Completed - Clinical trials for Diabetes Mellitus, Type 2

Effect of Pioglitazone Versus Metformin on Bone Health in Postmenopausal Women With Type 2 Diabetes

Pioglitazone
Start date: January 2009
Phase: Phase 2
Study type: Interventional

The study tests whether pioglitazone (PIO)as compared to metformin (MET)affects bone health including bone mineral density, bone turnover markers, and osteocyte biomarker in patients with type 2 diabetes (T2DM).

NCT ID: NCT01914601 Completed - Clinical trials for Need Tracheal Intubation

King Vision and Cervical Spines Movement

Start date: January 2014
Phase: Phase 2
Study type: Interventional

Extensive cervical spines movement during endotracheal intubation can result in serious neurological injury, especially in the patients with unrecognized cervical spines injury.[1-2] Moreover, direct laryngoscopy may be difficult if spine movement is limited because of arthritis, disc disease or a small gap between the occiput and the spinous process of the atlas.[3-4] Video laryngoscopes allow for intubation without alignment of the oral, pharyngeal, and tracheal axes which minimize the cervical movements, especially in the patients with restricted cervical movements. [5,6] Compared with the Macintosh laryngoscope, the use of AirWay Scope decreases median upper cervical-spine movement during intubation under in-line stabilization in patients with normal cervical-spine. [6] Unfortunately, the use video laryngoscopes are associated with longer times to tracheal intubation compared with the traditional techniques which may be attributed to the variable learning curves of the practitioners. [7-9] The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is an anatomically shaped, rigid laryngoscope that uses fiberoptic technology to view the larynx with micro camera offers a 160 degree of view potentially eliminating the need for neck flexion and head extension. [10] To the best of the authors' knowledge, there is no study has evaluated the King vision laryngoscope regarding the neck movement during routine tracheal intubation under general anesthesia.

NCT ID: NCT01914523 Completed - Clinical trials for Patients Need Tracheal Intubation

Comparison of the Macintosh, King Vision®, Glidescope® and AirTraq® Laryngoscopes in Routine Airway Management

Start date: September 2013
Phase: Phase 1/Phase 2
Study type: Interventional

Failure to successfully intubate the trachea and secure the airway remains a leading cause of morbidity and mortality, in the operative [1-2] and emergency settings. [3-4]. When the concept of endotracheal intubation was developed, 100 years ago the procedure was performed blindly. Shortly thereafter, laryngoscopes were invented, allowing for direct visualization of the larynx with a viewing angle of 15 degrees [5]. Insufficient laryngoscopic view constitutes the main reason for difficult intubations [6]. Video laryngoscopes provide an improved view of the glottis, as the camera is a few millimeters away from the glottis. The use of Glidescope [7-8] and AirTraq [9] laryngoscopes has superior glottis view and ease of tracheal intubation compared with the traditional Macintosh laryngoscope. Unfortunately, the use video laryngoscopes is associated with longer time to tracheal intubation compared with the traditional techniques which be explained with the variable learning curves of the practitioners. [10] The King Vision video laryngoscope® (King Systems Company, a division of Consort Medical, Indianapolis, Indiana, USA) is a relative newcomer to the video laryngoscopes of devices that claim to provide the "perfect view" for intubation via use of video and digital technology. The King Vision Video laryngoscope is a two piece design. It has a reusable monitor that attaches to disposable blades. Blades are made of high quality poly-carbonate plastic and house a complementary semi-conductor (CMOS) micro camera offers a 160 degree of view and LED light source. Up to best of the authors' knowledge, there is no current published or ongoing randomized controlled comparative study of the use of King Vision laryngoscope with traditional laryngoscope and other video laryngoscopes for endotracheal intubation.